BACKGROUND: This study examined the 6-month follow-up outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), compared to Psychoeducation about sleep and health (PE). METHODS: Adolescents (mean [SD] = 14.77 [1.84] years) with eveningness chronotype and at-risk in at least one of five health domains were randomized to receive TranS-C (n = 89) or PE (n = 87) at a university-based clinic. Primary outcomes were average weeknight total sleep time and bedtime calculated from sleep diary, a questionnaire measure of circadian preference, and composite risks in five health domains. Secondary outcomes were selected sleep diary indices, sleepiness, and self- and parent-reported sleep, parent-reported risks in five health domains. RESULTS: Relative to PE, TranS-C showed treatment effects through 6-month follow-up on only one primary outcome; namely eveningness circadian preference. TranS-C also showed treatment effects on two sleep and circadian secondary outcomes, including the Pittsburgh Sleep Quality Index and sleep-diary measured weeknight-weekend discrepancy in wakeup time. TranS-C did not show treatment effects on self-report or parent-report composite risks in five health domains. PE showed benefit, relative to TranS-C, from posttreatment to 6-month follow-up for reducing parent-reported behavioral health risk (secondary outcome). CONCLUSIONS: In at-risk adolescents, the evidence supports the TranS-C treatment effects over six months on improving sleep and circadian functioning on selected outcomes but not on reducing risk in five health domains.

BACKGROUND:The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). METHOD/DESIGN:Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). DISCUSSION:The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.